Status:
COMPLETED
TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Klinefelter Syndrome
Eligibility:
MALE
31-90 years
Phase:
PHASE4
Brief Summary
This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about the effect of testosterone on early health and development. The study is a total of three visits over 6 mon...
Detailed Description
XXY (also known as Klinefelter syndrome) is the most common chromosomal abnormality in males, affecting 1/600 boys. The extra X chromosome leads to insufficient development of the testicles and subseq...
Eligibility Criteria
Inclusion
- Male infants with 47,XXY karyotype identified prenatally who are 4-12 weeks old (31 to 90 days of age). 47,XXY must be from a diagnostic test such as Chorionic Villus Sampling (CVS), amniocentesis, or post-natal blood/tissue. Non-invasive prenatal screening results alone will not be accepted.
Exclusion
- \>20 percent mosaicism for a normal cell line
- Gestational age at birth \<36 weeks
- Birth weight \<2.5th percentile or \>97.5 percentile for age (small or large for gestational age)
- History of thrombosis in self or a first degree relative
- Exposure to androgen therapy outside the study protocol
- Use of medications known to affect body composition, such as growth hormone or insulin
- Known allergy to the testosterone cypionate solution components including benzyl benzoate, benzyl alcohol, or cottonseed oil
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03325647
Start Date
November 6 2017
End Date
May 5 2021
Last Update
May 6 2022
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045